NCT05371639

Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in Mild to Moderate Vascular Dementia

Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in the Treatment of Mild to Moderate Vascular Dementia: a Randomized, Placebo Controlled, Double Blind, Parallel Group, Multicenter Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will be a 36-week multicentre, double-blind, placebo-controlled phase Ⅱb trial in China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi Gan group (84mg per day) or to placebo group. The primary endpoint will be Vascular Dementia Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of Boxes. Secondary outcomes included changes in Mini-Mental State Examination, Clock Drawing Test, Delayed Story Recall and Ability of Daily Living. Patients' safety will be assessed by recording of adverse events, clinical examinations, electrocardiography and laboratory tests. The patients, caregivers, and investigators will be blinded to the treatment allocations.

Conditions

• Vascular Dementia
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Tian Ma Bian Chun Zhi Gan Tablets	Tian Ma Bian Chun Zhi Gan Tablets, 0.1g per pill which contains 14mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks.
DRUG	Placebo	Placebo identified to Tian Ma Bian Chun Zhi Gan, 0.1g per pill which contains 0mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks.

Timeline

• Start date: 2022-05-25
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2022-05-12
• Last updated: 2022-11-22

Locations

1 site across 1 country: China